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A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema

Trial Profile

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2019

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At a glance

  • Drugs Berotralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms APeX-J
  • Sponsors BioCryst Pharmaceuticals
  • Most Recent Events

    • 05 Nov 2019 According to a BioCryst Pharmaceuticals media release, BioCryst plans to submit a Japanese New Drug application (JNDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in the first quarter of 2020.
    • 06 Aug 2019 Planned End Date changed from 1 May 2020 to 1 Jun 2020.
    • 06 Aug 2019 Planned primary completion date changed from 1 Oct 2019 to 1 Nov 2019.
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